CEO Update|Monday 05 October

The BIA’s UK Bioscience Forum takes place next week 14-15 October and will focus on the opportunities and challenges of Emerging Data Technologies in the life sciences.  The full programme is available here featuring speakers from IQVIA, NICE, Benevolent AI, Lifebit, Babylon, AWS, Deepmatter, Closed Loop Medicine, Mogrify, Elsevier, Stratagem IPM, Microsoft, Illumina, Novartis Biome, Milner Therapeutics Institute, Oxford Nanopore, UK Biobank, IBM, Sensyne and UKRI amongst others.  The conference includes 1-1 video meeting within the platform, plus access to the content for two months after the event.  If you’re looking at the bigger data picture or interested in how you can incorporate data technology capabilities within your organisation, don’t miss out - book here.

Brexit update

To read our instant reaction to the Health Secretary's announcement that the MHRA will join Project Orbis, please follow this link.

There was no news of any substantive breakthrough on talks between the UK and EU over the weekend, even though the Prime Minister and the President of the European Commission spoke on Saturday. Every day without progress towards an agreement brings a non-negotiated outcome closer.

This risk has sharpened industry interest in the newly announced Medicines and Healthcare Products Regulatory Agency (MHRA) guidance webinars. The webinars will run from 19 October to 29 October and cover new guidance, with topics ranging from UK supply chain regulation to regulation of medical devices. Original capacity for these webinars was set at 500 and the sessions quickly became full. Following representations from the BIA last week, the capacity has now been increased to 3,000 for each of the nine webinars. Please contact our Head of Regulatory Affairs, Dr Christiane Abouzeid, if you are having any difficulties in accessing these webinars.

Updated MHRA guidance

In addition, the MHRA has published guidance on supplying medicines to Northern Ireland from 1 January 2021. Medicines placed on the market in the EU or the UK before 11pm GMT on 31 December 2020 may continue to circulate between these two markets from 1 January 2021. Article 41 of the Withdrawal Agreement enables these medicines to remain available for sale or supply between Great Britain, Northern Ireland and the EU after 1 January 2021, without additional regulatory checks. However, clarification on interpretation of Article 40 of the Withdrawal Agreement is still subject to agreement from government and may result in changes to these arrangements.

The MHRA has also published guidance on how the MHRA will manage orphan medicinal products from 1 January 2021.

The Brexit Health Alliance (BHA), of which the BIA is a member, has published a briefing that highlights the key agreements that are required to protect patients as part of the UK’s future relationship with the EU from 1 January 2021. It also lays out what will be required to protect patients in the event of a non-negotiated outcome.

We still don’t have clarity on Northern Ireland, no details on how and when to book alternative routes for Tier One goods and have seen news from other sectors on ’cumulation’ of rules of origin being unhelpful. All this whilst COVID -19 continues to rise on both sides of the Channel.

COVID-19 update

We saw useful clarity today from Kate Bingham, Chair of the UK Vaccines Taskforce, on the priority groups likely to be vaccinated first in the event of a vaccine being licensed. The Taskforce has produced a series of podcasts ‘COVID-19: the search for a vaccine’ where you can discover much more about the ongoing work – well worth a listen. 

This comes as we see continued collaboration within our sector, Cobra Biologics has teamed up with Scancell to manufacture their COVID-19 vaccine candidate. The agreement covers Good Manufacturing Practice (GMP) production of plasmid DNA needed to generate the DNA vaccine for use in a Phase 1 clinical trial in 2021. The project is funded by an Innovate UK grant awarded to the consortium between Scancell, the University of Nottingham, and Nottingham Trent University.

I was also heartened to hear first-hand from those at the forefront of vaccine development last week at the BIA’s regional event focussed on vaccine manufacturing at Harwell. It was great to be joined by Matthew Duchars, CEO of the Vaccines Manufacturing and Innovation Centre (VMIC), James Naismith, Director of the Rosalind Franklin Institute, talking about nanobodies, and Ailsa Powell, Industrial Liaison Scientist of Diamond Light Source. This topic will be discussed in more detail at our upcoming 17th Annual bioProcess UK Conference this December, find out more here.

Future Leaders Fellowships

The Future Leaders Fellowships (FLFs) are open for another round, to fund the most promising early career researchers and innovators from business and academia with up to £1.5m available over four years. We need more business applications to this excellent scheme.

The UK Research and Innovation (UKRI) scheme offers talented future leaders the opportunity to secure unprecedented levels of funding and support, to pursue world class research and innovation and push their careers to the next level. There is a webinar taking place this Friday with information about how you can get involved, register here.

On the topic of funding, I would like to remind members that the Biomedical Catalyst competition closes on 7 October. UK-registered SMEs can apply for a share of up to £30 million to develop a product or process that is an innovative solution to a health and care challenge. Find out more here.

Biotech LGBTQ group OUTbio UK launches

OUTbio, an independent network run specifically for the LGBTQ community and its allies in biotech has launched in the UK. OUTbio UK will be planning future events to welcome more members as the network grows. If you’d like to be part of OUTBio UK or be kept up-to-date with upcoming events or join the mailing list, please contact Grant Hawthorne.

Upcoming events

In these unprecedented times, cross-border collaboration and insights are more important than ever for our sector. Register for the 7th BioCentury-BayHelix China Healthcare Summit (Nov. 9-13, digital event) and access 1x1 Virtual Meeting System, starting Sept. 28. BIA members can receive 15% discount off tickets, find out more here.

World Arthritis Day

Monday October 12 is World Arthritis Day and our charity partner, Versus Arthritis, is encouraging everyone to share a message of strength on social media. Versus Arthritis wants each person with arthritis to know that their community is with them whenever they need it. Because society dismisses arthritis as ‘just aches and pains’ or ‘just a bit of wear and tear’, people often don’t recognise the strength it takes to live with arthritis. Find out more about the campaign here and keep up to date with Versus Arthritis here.

We look forward to hearing more about Versus Arthritis’ research at the upcoming UK Bioscience Forum where a panel will discuss the central role charities can play in addressing complex and challenging areas of research that have proven difficult for the bioindustry to crack.

Pathway – a new website for prospective non-executive directors

The Association of Investment Companies (AIC) has launched a new website for people interested in finding out more about becoming an investment company director. Pathway provides a range of helpful free resources for potential board candidates, including guides and videos explaining how investment companies work, what directors do, and how new directors are recruited.

 

Finally, a reminder that the BIA’s 2020 Annual General Meeting (AGM) will be held virtually on 21 October. Each member company of the BIA has voting rights at our AGM and the opportunity to select Board members to represent them.  The full details regarding each candidate and the voting process are available here.

Best,

Steve Bates

Chief Executive Officer

BIA

Steve Bates has been the CEO of the UK Bioindustry Association since 2012. He currently chairs the International Council of Biotech Associations and has been a Board member of Europabio since 2015. Steve is the visible face of the vibrant UK life sciences industry to government and media. He sits on the UK’s Life Sciences Council and Life Sciences Industrial Strategy Implementation Board. Steve has championed with government effective industrial incentives like the Biomedical Cataylst which have crowded-in private sector investment into UK SMES. He has forged links for the sector across the USA, Europe and in China. In his time at the BIA Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before the BIA, Steve worked for Genzyme and as an advisor to the UK Government of Tony Blair. He was made OBE for services to innovation in 2017.